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Oxidative Stress Parameters, Trace Element and Quality of Life in Women Before and After Covid-19 Vaccines

Primary Purpose

Covid-19 Vaccine

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
CoronoVac Vaccine
Sponsored by
Izmir Bakircay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Covid-19 Vaccine focused on measuring Covid-19, CoronaVac vaccine, Healthy women

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Agree to voluntarily participate in the study

Exclusion Criteria:

  • Have been taking trace element supplements for the past 2 weeks
  • Being pregnant
  • Body mass index over 40 kg/m2
  • Diagnosed with Covid-19 in advance
  • Not diagnosed with any chronic disease

Sites / Locations

  • Kadirhan Ozdemir

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CoronoVac Vaccine Group

Arm Description

Outcomes

Primary Outcome Measures

Change of the levels of Oxidative Stress Parameter 1
Oxidative Stress Parameter including Superoxide Dismutase (SOD) will be studied by photometric method in Medical Biochemistry Laboratory.
Change of the levels of Oxidative Stress Parameter 2
Oxidative Stress Parameters including Malondialdehyde (MDA) will be studied by photometric method in Medical Biochemistry Laboratory.
Change of the levels of Oxidative Stress Parameter 3
Oxidative Stress Parameter including Total Antioxidant Level (TAL) will be studied by photometric method in Medical Biochemistry Laboratory.
Change of the levels of Oxidative Stress Parameter 4
Oxidative Stress Parameters including Total Oxidant Level (TOL) will be studied by photometric method in Medical Biochemistry Laboratory.
Change of the levels serum trace element 1
Serum trace element including zinc levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Change of the levels serum trace element 2
Serum trace elements including selenium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Change of the levels serum trace element 3
Serum trace element including potassium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Change of the levels serum trace element 4
Serum trace element including sodium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Change of the levels serum trace element 5
Serum trace elements including calcium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Change of the levels serum trace element 6
Serum trace element including magnesium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Change of the levels serum trace element 7
Serum trace element including copper levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Change of the levels of quality of life
SF-36 Quality of Life Scale will be used to determine the quality of life level. The scale that patients can apply themselves and in a short time; It consists of 36 items and 8 subsections. These sections are physical functionality, social functionality, role restrictions due to physical problems, role restrictions due to emotional problems, pain, energy level / vitality / vitality, mental health, and general health perception (40). The last 4 weeks are considered in the evaluation of the scale. The scale gives a separate total score for each subsection. The points obtained from the subsections are not added up. Subdivisions rate health from 0 to 100. While it expresses bad health status as "0 points", it refers to good health status as "100 points".

Secondary Outcome Measures

Full Information

First Posted
February 9, 2021
Last Updated
February 11, 2021
Sponsor
Izmir Bakircay University
Collaborators
Cigli Regional Training Hospital, Muğla Sıtkı Koçman University
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1. Study Identification

Unique Protocol Identification Number
NCT04751721
Brief Title
Oxidative Stress Parameters, Trace Element and Quality of Life in Women Before and After Covid-19 Vaccines
Official Title
Comparison of Oxidative Stress Parameters, Trace, Element and Quality of Life Levels in Healthy Women Before and After Covid-19 Vaccines
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Bakircay University
Collaborators
Cigli Regional Training Hospital, Muğla Sıtkı Koçman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
There is no effective treatment method for COVID-19 yet. With vaccination being the most effective approach to control the COVID-19 pandemic, vaccines have been developed with many different methods. One of the vaccines developed, the China-based CoronaVac vaccine (inactivated + aluminum adjuvant vaccine) is a vaccine developed with the inactive method, which is the classical vaccine production method. As a result of Phase 1, Phase 2 and Phase 3 trials, emergency use approval has been given for the CoronaVac vaccine by Turkish Pharmaceuticals and Medical Devices Agency. The clinical picture of COVID-19 can be heterogeneous, ranging from asymptomatic to severe disease, which can be associated with a cytokine storm. In the clinical results of COVID-19, it has been observed that the severity of the disease is lower in women than in men, and the mortality rates are lower in women than in men. A few studies have shown the physiological roles of some vitamins and trace elements in COVID-19. Investigation of free radical levels known to be effective in the development of cardiovascular disease due to oxidative stress is important in determining the risk of cardiovascular complications in the COVID-19 pandemic. In addition, the social isolation rules and quarantine measures applied in the COVID-19 pandemic have caused individuals to be negatively affected physically and psychologically and their quality of life to decrease. Investigating the changes in oxidative stress parameters, trace element and quality of life levels of vaccination in COVID-19 may provide useful information in determining the effects of COVID-19 vaccine. It is planned to include female individuals to be vaccinated in Izmir Bakırcay University Cigli Training and Research Hospital. Within the scope of the study, it was planned to determine the oxidative stress parameters, trace element levels and quality of life levels of the individuals and to compare the values of the data obtained before and after vaccination. After analyzing the data obtained from the research with appropriate statistical methods, the data will be evaluated.
Detailed Description
Coronavirus disease 2019 (COVID-19) pandemic, also known as Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), caused by a coronavirus strain that is a member of the Betacoronavirus genus, affecting billions of people worldwide, has become a global health problem. Since vaccination is the most effective approach to control the COVID-19 pandemic, trials of many different vaccines have been started. According to the data of the World Health Organization, there are 236 vaccines in total, with clinical (63) and pre-clinical (173) studies developed using 10 different methods.Types of vaccines for COVID-19 include conventionally live attenuated viruses, inactivated virus protein or polysaccharide conjugated subunit vaccines, virus-like particles (VLPs), nucleic acid (DNA and RNA), viral vectors (replicating and non-replicating), and the other vaccines composed of eccombinant proteins. CoronaVac vaccine (inactivated + aluminum adjuvant vaccine) is a vaccine developed by the biopharmaceutical company named Sinovac Biotech Ltd. based in China, using the classical vaccine production method (inactive method). After the completion of Phase 1 and Phase 2 trials of the vaccine, Phase 3 trials were initiated in Turkey. Emergency use approval has been given for the CoronaVac vaccine by Turkish Pharmaceuticals and Medical Devices Agency after the end of these trials.Although the pathogenesis of COVID-19 is not fully understood, its clinical presentation may become heterogeneous, ranging from asymptomatic to severe disease. It has been reported that a systemic hyperinflammatory response and associated thromboembolic complications are observed in cases with severe symptoms. In addition, it has been observed that the severity of the disease and mortality rates are lower in women compared to men in the clinical results of COVID-19. The roles of vitamins A, B, C, D, E and folate and trace elements such as iron, zinc, magnesium, selenium and copper in supporting the immune system have been shown to have positive effects on COVID-19 disease. Intermediates in enzymatic reactions occurring during cell metabolism (reactive oxygen species and reactive nitrogen) sometimes leak from the active site of enzymes and accidentally interact with molecular oxygen and form free oxygen radicals. Oxidative stress caused by free oxygen radicals forms the molecular basis in the development of cancer, neurodegenerative and cardiovascular diseases, diabetes and autoimmune disorders. Social isolation rules and quarantine measures have negatively affected the daily lives of individuals physically and psychologically. In particular, the increase in the time spent at home causes individuals to have a sedentary life and cause their physical levels to decrease. This situation caused individuals to be psychologically affected by concerns about health, news watched, and the increasing number of cases day by day. Studies have also reported negative psychological effects such as post-traumatic stress symptoms, confusion, disappointment, feeling of isolation and anger as a result of quarantine. These psychological and physical effects caused by the COVID-19 pandemic caused a decrease in the quality of life of individuals. During the COVID-19 pandemic, it has been reported that the depression and anxiety levels of healthcare workers increased and their quality of life decreased. The aim of this study is to compare and determined and the changes of oxidative stress parameters, trace element and quality of life levels in healthy women just before the first dose of COVID-19 vaccine and on the 7th day after the second dose of COVID19 vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19 Vaccine
Keywords
Covid-19, CoronaVac vaccine, Healthy women

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CoronoVac Vaccine Group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
CoronoVac Vaccine
Intervention Description
CoronaVac vaccines will be inoculated in 2 doses with an interval of 24 days.
Primary Outcome Measure Information:
Title
Change of the levels of Oxidative Stress Parameter 1
Description
Oxidative Stress Parameter including Superoxide Dismutase (SOD) will be studied by photometric method in Medical Biochemistry Laboratory.
Time Frame
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Title
Change of the levels of Oxidative Stress Parameter 2
Description
Oxidative Stress Parameters including Malondialdehyde (MDA) will be studied by photometric method in Medical Biochemistry Laboratory.
Time Frame
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Title
Change of the levels of Oxidative Stress Parameter 3
Description
Oxidative Stress Parameter including Total Antioxidant Level (TAL) will be studied by photometric method in Medical Biochemistry Laboratory.
Time Frame
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Title
Change of the levels of Oxidative Stress Parameter 4
Description
Oxidative Stress Parameters including Total Oxidant Level (TOL) will be studied by photometric method in Medical Biochemistry Laboratory.
Time Frame
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Title
Change of the levels serum trace element 1
Description
Serum trace element including zinc levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Time Frame
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Title
Change of the levels serum trace element 2
Description
Serum trace elements including selenium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Time Frame
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Title
Change of the levels serum trace element 3
Description
Serum trace element including potassium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Time Frame
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Title
Change of the levels serum trace element 4
Description
Serum trace element including sodium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Time Frame
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Title
Change of the levels serum trace element 5
Description
Serum trace elements including calcium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Time Frame
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Title
Change of the levels serum trace element 6
Description
Serum trace element including magnesium levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Time Frame
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Title
Change of the levels serum trace element 7
Description
Serum trace element including copper levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Time Frame
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Title
Change of the levels of quality of life
Description
SF-36 Quality of Life Scale will be used to determine the quality of life level. The scale that patients can apply themselves and in a short time; It consists of 36 items and 8 subsections. These sections are physical functionality, social functionality, role restrictions due to physical problems, role restrictions due to emotional problems, pain, energy level / vitality / vitality, mental health, and general health perception (40). The last 4 weeks are considered in the evaluation of the scale. The scale gives a separate total score for each subsection. The points obtained from the subsections are not added up. Subdivisions rate health from 0 to 100. While it expresses bad health status as "0 points", it refers to good health status as "100 points".
Time Frame
Immediately before the first dose and 4 weeks later

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Agree to voluntarily participate in the study Exclusion Criteria: Have been taking trace element supplements for the past 2 weeks Being pregnant Body mass index over 40 kg/m2 Diagnosed with Covid-19 in advance Not diagnosed with any chronic disease
Facility Information:
Facility Name
Kadirhan Ozdemir
City
İzmir
ZIP/Postal Code
06580
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Oxidative Stress Parameters, Trace Element and Quality of Life in Women Before and After Covid-19 Vaccines

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